Proposed Regulatory Framework for Direct-to- Consumer Genetic Testing: Diagnostics vs. Genetic Screening To the Editor:

stopped marketing direct-to-consumer (DTC)1 disease-predictive genetic testing to comply with the FDA’s directive (1). Although the FDA’s action was intended to pro-tect the American public from questionable disease risk predic-tions, we believe the agency failed to assess all the benefits of DTC testing. Despite assurances assert-ing support for consumer genetic testing (2), the FDA’s action strongly discourages DTC provid-ers from offering the tests to con-sumers, undermining the invest